ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
FDA 510(k) clearance K043067 · decided 2005-05-31
Clearance details
- K-number
- K043067
- Device name
- ENA IGG BEADCHIP TEST SYSTEM, ARRAY IMAGING SYSTEM, MODELS 800-00025, AIS 400
- Applicant
- Bioarray Solutions, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2004-11-08
- Decision date
- 2005-05-31
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- LLL
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Warren, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.